Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions

The investigators aim to study the brain mechanisms underlying the effect of subliminal (not consciously perceived) intragastric administration of bitter tastants on hunger and food intake, which was previously found. The investigators will assess brain activation patterns after an acute intragastric administration of Quinine-hydrochloride versus saline on two different test days, and will simultaneously assess a putative role of altered gut peptide release in these effects. The hypothesis is that intragastric infusion of a bitter agonist will decrease the activity in homeostatic and hedonic brain regions and that this effect is mediated by gut peptide release.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Control; Other: Quinine hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy volunteers
• Female
• N = 15
• Age 18 - 60
• Body Mass Index (BMI) of 20 - 25 kg/m
• Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

• Abdominal or thoracic surgery. Exception: appendectomy
• Gastrointestinal, endocrine or neurological diseases
• Cardiovascular, respiratory, renal or urinary diseases
• Hypertension
• Food or drug allergies
• Anemia
• Eating disorders and people who show abnormal eating behavior
• Depressive disorders
• Psychotic disorders
• No medication on a regular basis, expect for oral contraception
• Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, …
• No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
• Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
• Dieters
• Pregnant or breastfeeding women
• Claustrophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Intragastric infusion	Other: Control; Intragastric administration of distilled water
Experimental: Quinine hydrochloride; Intragastric infusion	Other: Quinine hydrochloride; Intragastric administration of a bitter tastant agonist (10 μmol/kg quinine-hydrochloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional brain images	Change in brain responses after administration compared to baseline will be assessed via functional magnetic resonance imaging.	From the start of the study until 50 minutes after the start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hunger scores	The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.	every 10 minutes since the scan starts until until 50 minutes after the start of the scan
Ghrelin levels	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure ghrelin levels by radioimmuno-assay.	every 10 min since the scan starts until 50 minutes after the start of the scan.
Motilin levels	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure motilin levels by radioimmuno-assay.	every 10 min since the scan starts until 50 minutes after the start of the scan
CCK levels	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure CCK levels by radioimmuno-assay.	every 10 min since the scan starts until 50 minutes after the start of the scan
PYY levels	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure PYY levels by Enzyme-Linked Immuno Sorbent Assay	every 10 min since the scan starts until 50 minutes after the start of the scan
GLP-1 levels	Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure GLP-1 levels by Enzyme-Linked Immuno Sorbent Assay	every 10 min since the scan starts until 50 minutes after the start of the scan

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jan Tack, Prof, University of Leuven

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antiprotozoal Agents; Antiparasitic Agents; Neuromuscular Agents; Antimalarials; Muscle Relaxants, Central; Quinine
• Other Study ID Numbers: S57915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO